Lovells

Biogen reined in again

In a unanimous decision, the House of Lords has today dismissed the appeal of Generics (UK), Arrow Generics and Teva against the Court of Appeal's decision upholding Lundbeck's patent for the anti-depressant escitalopriam (Cipralex).  In doing so, the House of Lords has clarified the scope of so called 'Biogen insufficiency', namely the extent to which the claims of a patent must correspond with the inventive concept.  In short, the House of Lords has held that in the case of a simple product claim, if the product is new and not obvious and the patent specification is enabling, the patent cannot be invalid for insufficiency even though the patent only discloses one way of making the product. 

Escitalopram is the (+)enantiomer of the racemate citalopram.  Citalopram itself was first sold by Lundbeck as an anti-depressant in 1989 and the patent for citalopram has long since expired.  In 1988, Lundbeck succeeded in resolving the racemate to enable the manufacture of the therapeutically active (+)enantiomer on its own. 

At trial, Kitchin J held that as the patent only disclosed one way to make the (+)enantiomer, it would be a monopoly disproportionate to Lundbeck's technical contribution if the patent effectively covered all ways of making the (+)enantiomer.  He commented that "the first person to find a way of achieving an obviously desirable goal is not permitted to monopolise every other way of doing so".  In reaching his conclusion, Kitchin J relied solely upon the House of Lords decision in Biogen v Medeva [1997].

According to the Court of Appeal and now the House of Lords, the crucial difference from the Lundbeck patent was that the Biogen patent did not contain a simple product claim, but a complex product-by-process claim, relating to a broad class of products.  The Biogen patent was insufficient because its specification did not enable the invention to be performed across the full extent of the patent claims.  In contrast, in the Lundbeck case, despite the fact that the racemate and the (+)enantiomer were well known and resolving the racemate was a desirable goal, there was no known way of producing the (+)enantiomer alone.  As Lundbeck's method for producing the (+)enantiomer was new and not obvious (and this was not challenged on appeal to the House of Lords), the House of Lords agreed with the Court of Appeal that Lundbeck was entitled to a patent for the (+)enantiomer as such, regardless of how it is made.

In upholding the Court of Appeal's judgment, the House of Lords emphasises the importance of taking account of the clear jurisprudence of the European Patent Office.  In this regard, the House of Lords considered in detail the EPO Technical Boards of Appeal decisions in T409/91 EXXON and T595/90 Kawasaki. 

Central to the House of Lords' decision was an extensive debate about the extent to which the "technical contribution to the art" of a patent should coincide with the "inventive concept" disclosed in the patent.  While this was not entirely resolved, the overall conclusion was that in the case of a simple product claim, even though the inventive step may be a process, the technical contribution is the product itself, by virtue of the patent enabling the product to be made available for the first time. 

Comment

The issue of the appropriate scope of patent claims has been a hot topic ever since the Patents Act 1977 appeared to have abolished the ground of revocation previously known as lack of fair basis under the Patents Act 1949.  The Court of Appeal first wrestled with this issue in 1988 in Genentech's Patent.  It concluded at the time that there was no ground for revocation under the 1977 Act which corresponds to Article 84 EPC, namely that "the claims shall... be supported by the description".  However following the House of Lords' decisions in Asahi KKK's Application [1991] and Biogen [1997], the consensus seemed to be that if the patent specification discloses the invention in a way which enables it to be performed by a person skilled in the art to the full extent of the claims (ie an enabling disclosure), then the claims are also supported by the description.  Thus the requirements of both Articles 83 and 84 EPC (and the corresponding sections 14(3) and 14(5)(c) Patents Act 1977) are fulfilled. 

This is an important decision and one whose effects are not limited to the life sciences field.  It is now clear that provided the patent disclosure is enabling, scrutiny as to the precise scope of the claims relative to the technical contribution or inventive concept will rarely be appropriate.  A separate and interesting issue, which we first mentioned in our Newsflash relating to the Court of Appeal decision in this case, is the question of how much more than 50% of the (+)enantiomer must be present for a product to fall within the product claims of a patent for the (+)enantiomer.  This is unlikely to be an issue in practice as a marketing authorisation will either relate to the racemate or to the therapeutically active enantiomer. 

Interestingly, Lundbeck's corresponding European (DE) patent for escitalopram was held invalid at first instance, but for lack of novelty.  Lundbeck's appeal to the German Federal Supreme Court was not expected to be decided until next year or 2011, however the appeal may now be heard sooner as the Federal Supreme Court has recently established a second senate for patent matters.  In view of the Federal Supreme Court's recent decision in the Eli Lilly olanzapine case, which expressly referred to the EPO's caselaw on enantiomers, it is hoped that the escitalopram appeal will also be decided in favour of Lundbeck.  This would be good news for both Lundbeck and the innovator pharmaceutical industry, and the harmonisation of legal approaches would reduce uncertainty in the enforcement of patents across Europe.